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(2006.01) A61P 25/36 (2006.01) A61K 9/00 (2006.01) (21) International Application Number: PCT/US20 19/059852 (22) International Filing Date: 05 November 2019 (05

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(2006.01) A61P 25/36 (2006.01) A61K 9/00 (2006.01) (21) International Application Number: PCT/US20 19/059852 (22) International Filing Date: 05 November 2019 (05 ( (51) International Patent Classification: A61K 31/485 (2006.01) A61P 25/36 (2006.01) A61K 9/00 (2006.01) (21) International Application Number: PCT/US20 19/059852 (22) International Filing Date: 05 November 2019 (05. 11.2019) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/756,322 06 November 2018 (06. 11.2018) US 62/820,582 19 March 2019 (19.03.2019) US (71) Applicant: PURDUE PHARMA L.P. [US/US]; One Stamford Forum, 201 Tresser Boulevard, Stamford, CT 06901 (US). (72) Inventors: HUANG, Haiyong, Hugh; 5 Millar Court, Princeron Junction, NJ 08550 (US). SHET, Manjunath, S.; 22 Wimbledon Court, White Plains, NY 10607 (US). (74) Agent: KOPELEVICH, Sofia et al.; Lowenstein Sandler LLP, One Lowenstein Drive, Roseland, NJ 07068 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available) : AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW,KZ, LA, LC, LK, LR, LS, LU, LY,MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available) : ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, Cl, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) (54) Title: COMPOSITIONS AND METHODS FOR OPIOID ANTAGONIST DELIVERY (57) Abstract: Disclosed in certain embodiments is a pharmaceutical formulation (e.g., parenteral formulation) comprising a therapeu¬ tically effective amount of nalmefene or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable adjuvant (e.g., parenterally acceptable adjuvant) that promotes the rate at which the nalmefene or salt thereof is more rapidly absorbed into the systemic circulation of a subject identified as in need thereof. COMPOSITIONS AND METHODS FOR OPIOID ANTAGONIST DELIVERY FIELD OF THE INVENTION [0001] In certain embodiments, the present invention relates to the field of pharmaceutical compositions for rescuing a subject from an opioid overdose, methods of providing overdose rescue, pre-dosing a subject as protection against opioid overdose prior to entering an environment where opioid exposure may occur, methods for treating alcohol dependence, methods for treating constipation, and drug delivery systems thereof. BACKGROUND OF THE INVENTION [0002] Pharmaceutical products are sometimes subject to abuse. For example, a particular dose of opioid analgesic may be more potent when administered parenterally as compared to the same dose administered orally. Abusing a pharmaceutical product may result in an overdose that could be fatal. Also, potent opioids can be used as toxic chemical agents intentionally or unintentionally to cause death in humans through exposing humans to lethal doses through aerosolizing or other means of dispersal. [0003] Symptoms of opioid overdose include, but not limited to, loss of consciousness, unresponsiveness to outside stimulus, being awake but unable to talk, respiratory depression or respiratory cessation, vomiting, limp body, pale or clammy skin, bluish fingernails and lips, slow heartbeat, erratic heartbeat, no heartbeat and eventual death. [0004] To counteract opioid overdose effects, emergency personnel or others may administer an antidote such as an intramuscular injection of an opioid antagonist. Given that the administered antidote needs to be absorbed into the bloodstream, there inevitably will be a lag from the time of antidote administration to the time that the antidote reaches therapeutic levels sufficient to effectively counteract the effects of the opioid. Unfortunately, this lag time can result in the antidote treatment not being effective enough in sufficient time to prevent morbidity and mortality due to the overdose. [0005] There exists a need in the art for a pharmaceutical composition for rescuing a subject from opioid overdose, and a method of rescuing a subject from an opioid overdose which method provides a rapid onset of action. OBJECTS AND SUMMARY OF THE INVENTION [0006] It is an object of certain embodiments of the present invention to provide a pharmaceutical composition (e.g., a parenteral formulation) for rescuing a subject from an opioid overdose, or for preventing (or reducing the risk in) a subject from experiencing an opioid overdose. [0007] It is an object of certain embodiments of the present invention to provide a parenteral formulation for rescuing a subject from an opioid overdose, or for preventing (or reducing the risk in) a subject from experiencing an opioid overdose. [0008] It is an object of certain embodiments of the present invention to provide a method for rescuing a subject from an opioid overdose, or for preventing (or reducing the risk in) a subject from experiencing an opioid overdose. [0009] It is an object of certain embodiments of the present invention to provide a method of prophylactically administering a pharmaceutical composition as disclosed herein to a subject (e.g., a first responder or a member of law enforcement) who is at risk of being exposed to a toxic amount of an opioid agonist (e.g., fentanyl, sufentanyl, carfentanyl, or a salt or derivative thereof). [0010] It is an object of certain embodiments of the present invention to provide a drug delivery system for rescuing a subject from an opioid overdose, or from preventing (or reducing the risk in) a subject (e.g., a first responder or a member of law enforcement) from experiencing an opioid overdose. [0011] It is also an object of certain embodiments of the present invention to provide pharmaceutical compositions, drug delivery devices and methods for the treatment of alcohol dependence, constipation and other conditions that may be treated with opioid antagonists. [0012] The above objects and others may be achieved by the present invention which in certain embodiments is directed to a pharmaceutical composition for providing opioid overdose rescue to a subject, or for preventing an opioid overdose in a subject. In certain embodiments, the pharmaceutical composition comprises a therapeutically effective amount of an opioid antagonist, and a parenterally acceptable absorption enhancing amount of an adjuvant that promotes, enhances, or quickens the systemic absorption rate of the opioid antagonist post intramuscular or subcutaneous injection. The adjuvant may be selected from appropriate absorption-enhancing agents currently known or those that would be readily appreciated by an ordinary skilled artisan (in formulation and medical fields) for such use. In certain non-limiting embodiments, the adjuvant comprises nitric oxide inducers, niacin, niacin derivatives, niacin metabolites phosphodiesterase inhibitors, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, calcium-channel blockers, nitrates or combinations thereof. [0013] In certain embodiments, the opioid antagonist comprises naloxone, naltrexone, nalmefene, pharmaceutically acceptable salts thereof, or combinations thereof. [0014] In certain embodiments, the pharmaceutical composition of the present invention comprises a therapeutically effective amount of nalmefene or a pharmaceutically acceptable salt thereof and an absorption-enhancing effective amount of a pharmaceutically acceptable adjuvant (e.g., parenterally acceptable adjuvant), wherein the composition provides atime to onset of action of the nalmefene of 5 minutes or less post intramuscular or subcutaneous injection to a subject experiencing, or at risk of experiencing an opioid agonist overdose. [0015] In certain embodiments, the composition provides a mean time to maximum plasma concentration of nalmefene of about 2.0 hours or less post intramuscular injection to a population of healthy subjects or about 1.0 hour or less post subcutaneous injection to a population of healthy subjects. [0016] In certain embodiments, the present invention is directed to an opioid overdose rescue method or an opioid overdose prevention method to a subject experiencing or at risk of experiencing an opioid (e.g., an opioid agonist) overdose, comprising intramuscularly, or subcutaneously administering to the subject a pharmaceutical composition as disclosed herein. [0017] In certain embodiments, the present invention is directed to a drug delivery system comprising a device containing a pharmaceutical composition as disclosed herein. In one embodiment, such a device is suitable for delivering the pharmaceutical composition through injection. In certain embodiments, the composition is contained within a pre-filled syringe, a vial, an injection pen, or an auto-injector. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The above and other features of the present invention, their nature, and various advantages will become more apparent post consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which: [0019] Figure 1 depicts the comparative mean plasma concentration
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